Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis

Despite high mortality and morbidity, the best treatment strategies for prosthetic valve thrombosis (PVT) have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different thrombolytic strategies.Transesophageal echocardiography (TEE) guided thrombolytic treatment was administered to 182 consecutive patients with PVT in 220 different episodes (156 women, mean age 43.2±13.06 years) between 1993 and 2009. These regimens included rapid streptokinase (Group I, 16 episodes), slow streptokinase (Group II, 41 episodes), high dose (100 mg) tissue plasminogen activator (t-PA) (Group III, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-PA without bolus (Group IV, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-PA without bolus (Group V, 124 episodes). The study endpoints were thrombolytic success and in-hospital mortality and non-fatal complication rates.

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Key information

Conditions

Prosthetic Valve Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kosuyolu Kartal Heart Training and Research Hospital

Istanbul, 34844, Turkey (Türkiye)

About this study

One hundred and eighty two consecutive in-hospital patients with 220 episodes of PVT between 1993 and 2009 were included in the study. The patients were enrolled after informed consent if there was no contraindication, to thrombolysis. The study was approved by the local Ethics Board. The patient demographics, past medical history, date of the operation, type and make of the prosthetic valve, rhythm disorders, aspirin use, NYHA functional capacity, leading symptoms and international normalization ratio (INR) values at the time of admission were prospectively entered into a database.The diagnosis of PVT was verified each time by transesophageal echocardiography (TEE) when a patient was admitted with thromboembolism or persistently low INR for the preceding consecutive 3 months and when a transthoracic echocardiography (TTE) documented prosthetic valve dysfunction or thrombus. All patients underwent TTE and TEE examination before and after the thrombolysis sessions. The cross sectional area and the longest diameter of the thrombus were measured on TEE recordings

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with prosthetic valve thrombosis

Exclusion criteria

Large left atrial thrombus
Recent (<3 weeks) ischemic stroke
Hemorrhagic stroke
Early (<4 days) postoperative period
Traumatic accident <4 weeks
Bleeding diathesis †
İntracranial mass
Active internal bleed
Aortic dissection

Treatment and study plan

Streptokinase

Drug

3-hour infusion of 1.5 million units of streptokinase (16 patients, 16 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units)

Other names: Streptase

tissue plasminogen activator

Drug

5-hour infusion of 90 mg t-PA (Tissue plasminogen activator) after 10 mg bolus (10 patients, 12 episodes), repeat once 24 hours later if needed (maximum total dose 200 mg)

Other names: ACTILYSE

Primary outcomes

Thrombolytic success

Time frame: 24 hours
In the absence of fatal or nonfatal major complications;
- Obstructive thrombus:
- Doppler documentation of the resolution of increased gradient and decreased valve area.
- Clinical improvement in symptoms.
- Reduction by ≥75% in major diameter or area of the thrombus. Complete success was defined when all 3 criteria were met and partial success was defined as less than 3.
- Nonobstrucive thrombus:
- Complete success: ≥75% reduction in thrombus area.
- Partial success: 50%-75% reduction in thrombus area.
Non-fatal complication rates

Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion.
- Nonfatal minor complication: Bleeding without need for transfusion, TIA.
In-hospital mortality

Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

All cause in-hospital mortality.

Sponsors and collaborators

Lead sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Other Gov

Registry information

Acronym: TROIA

Important dates

Study start: 1993
Primary completion: 2009
Study completion: 2009
First posted: Oct 13, 2011
Registry last updated: Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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